CN114177517A - Nerve stimulation electrode and nerve stimulation device - Google Patents

Abstract

The invention discloses a nerve stimulation electrode and a nerve stimulation device, and relates to the technical field of medical instruments. When the nerve stimulation electrode provided by the invention is used, a doctor does not need to cut the skin and flesh of a patient and does not need to fix a fixed anchor.

Description

Nerve stimulation electrode and nerve stimulation device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a nerve stimulation electrode and a nerve stimulation device.

Background

Neurostimulation devices have been widely used in the treatment of neurological disorders such as parkinson's disease. However, the nerve stimulation device in the prior art has complicated using steps, and requires a doctor to cut the skin and flesh of a patient, to make the implanting end of the nerve stimulation electrode close to the nerve to be stimulated, to fix the nerve stimulation electrode in the body by the fixing anchor, and to suture the skin and flesh. The use mode not only reduces the treatment efficiency, but also increases the difficulty of operation of doctors.

Disclosure of Invention

In order to solve the problems, the invention provides a nerve stimulation electrode, and when in use, a doctor does not need to cut skin and flesh of a patient and does not need to fix a fixing anchor.

In order to achieve the purpose, the invention adopts the following technical scheme:

a nerve stimulation electrode comprises a sleeve and a plurality of guide wires arranged in the sleeve, and further comprises a flexible contact connected to one end of each guide wire;

the nerve stimulation electrode stretches into the body, the flexible contact is deformed in the body and contacts with the nerve, and the deformed flexible contact is fixed in the body.

When the nerve stimulation electrode provided by the invention is used, one end of the flexible contact is connected with the inner cavity of the puncture needle, a doctor punctures the puncture needle into the body of a patient, and the nerve stimulation electrode enters the body of the patient together with the puncture needle. When the puncture needle reaches the designated position, the puncture needle is withdrawn, and the flexible contact and part of the guide wire and the sleeve are left in the body of the patient. The other end of the nerve stimulation electrode is arranged outside the body of the patient and is connected with a signal generator of the nerve stimulation electrode. The flexible contact is correspondingly deformed along with the muscle, the skeleton and the like of the patient in the body of the patient to form an inverted structure and contact the appointed nerve.

Optionally, the flexible contact is connected with the guide wire by laser welding, and a welding point of the flexible contact and the guide wire plugs the sleeve.

Optionally, the flexible contacts are insulated from each other by sealing compound.

Optionally, one end of the flexible contact, which is in contact with the nerve, is divided into a plurality of sub-contacts, and the sub-contacts are in contact with the nerve simultaneously.

Optionally, the flexible contact is a spring contact, or the flexible contact is a flexible metal contact.

Optionally, the guide wire is made of MP35N, 35NLT, stainless steel, platinum iridium alloy, and nickel titanium alloy.

Optionally, the guidewire is helical.

Optionally, the casing is made of PTFE, TTFE, PFA, PI, Nylon.

Optionally, through holes for the guide wires to pass through are formed in the sleeve, the number of the through holes corresponds to the number of the guide wires, and the guide wires pass through the through holes and are fixed in the sleeve.

Optionally, the sleeve is filled with a metal conductor.

Optionally, the outer surface of the cannula is coated with a biocompatible coating.

The invention has the following beneficial effects:

1. when the nerve stimulation electrode provided by the invention is used, the skin and the flesh of a patient are not cut, so that the flexible contact is retained and fixed in the body of the patient, and the formed inverted structure can prevent the flexible contact from displacing. Compared with the prior art that skin and flesh are cut and the fixed anchoring and suturing forms are adopted, the nerve stimulation electrode provided by the invention does not need the steps of cutting, fixing the anchor electrode, suturing and the like of a surgical operation, and is directly implanted into a body by adopting a puncture needle, so that the use time is less, the operation is simpler, the treatment efficiency is improved, the working difficulty of a doctor is reduced, and the workload of the doctor is reduced. Due to the flexible property of the flexible contact, the flexible contact can deform and be fixed along with the body property of a patient without a fixed anchor in the body of the patient, and the use cost of a hospital is saved.

2. Because the nerve stimulation electrode provided by the invention is applied to the medical field, the flexible contact and the guide wire are very soft and easy to damage, and the requirements on precision and sanitation are very high, so that the connection is carried out by adopting a laser welding mode, the loss rate in the production process can be avoided, and the requirements on precision and sanitation can be met. The plugging of the sleeve can be realized by each welding point, and the use stability of the nerve stimulation electrode is ensured.

3. The flexible contacts are insulated by sealing compound to avoid the occurrence of conduction short circuit between the flexible contacts, so that the stimulation signal is better transmitted to nerves.

4. One end of the flexible contact, which is contacted with the nerve, is divided into a plurality of sub-contacts, and the sub-contacts simultaneously contact the nerve and output stimulation signals to the nerve, so that the directionality carried by the single-ended flexible contact when outputting the stimulation signals is avoided. The stimulation signals output by the sub-contacts in different directions stimulate the nerves at the same time, so the directionality carried by the stimulation signals output by the single-ended flexible contact is offset, and the treatment effect is further improved.

5. The flexible contact is a spring contact or a flexible metal contact, so that the flexible contact has better extensibility after entering a human body, the deformation is softer, and the foreign body sensation of a patient is reduced.

6. The seal wire is the heliciform, promotes the tensile strength and the pliability of seal wire through the spiral shape for the seal wire can bear more bending times, obtains longer life.

7. The guide wire penetrates through the through hole and is fixed in the sleeve, and the sleeve is made of insulating materials, so that physical isolation between the guide wire and the guide wire is realized, conduction short circuit between the guide wires is avoided, and stimulation signals are better transmitted to nerves.

8. The metal conductor is filled in the sleeve, so that the whole nerve stimulation electrode has better signal conductivity, and the impedance is greatly reduced.

9. The biocompatible coating is coated on the outer surface of the sleeve, so that rejection reaction generated after the nerve stimulation electrode enters a human body can be reduced.

In addition, the invention also provides a nerve stimulation device, which comprises a nerve stimulation signal generator and the nerve stimulation electrode. The nerve stimulation electrode is connected with the nerve stimulation signal generator, and a nerve stimulation signal generated by the nerve stimulation signal generator is input into a human body through the nerve stimulation electrode to stimulate nerves. The neural stimulation device provided by the invention is similar to the neural stimulation electrode in beneficial effect reasoning process, and is not repeated herein.

These features and advantages of the present invention will be disclosed in more detail in the following detailed description and the accompanying drawings. The best mode or means of the present invention will be described in detail with reference to the accompanying drawings, but the present invention is not limited thereto. In addition, the features, elements and components appearing in each of the following and in the drawings are plural and different symbols or numerals are labeled for convenience of representation, but all represent components of the same or similar construction or function.

Drawings

The invention will be further described with reference to the accompanying drawings in which:

FIGS. 1 and 2 are schematic diagrams of a first embodiment of the present invention;

fig. 3 is a cross-sectional view of a first embodiment of the present invention.

The device comprises a sleeve 1, afirst guide wire 21, asecond guide wire 22, a firstflexible contact 31, a secondflexible contact 32, alaser welding point 4, asealing compound 5, abiocompatible coating 6 and ametal material 7.

Detailed Description

The technical solutions of the embodiments of the present invention are explained and illustrated below with reference to the drawings of the embodiments of the present invention, but the following embodiments are only preferred embodiments of the present invention, and not all embodiments. Based on the embodiments in the implementation, other embodiments obtained by those skilled in the art without any creative effort belong to the protection scope of the present invention.

Reference in the specification to "one embodiment" or "an example" means that a particular feature, structure or characteristic described in connection with the embodiment itself may be included in at least one embodiment of the patent disclosure. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

The first embodiment is as follows:

as shown in fig. 1 and 2, the present embodiment provides a nerve stimulation electrode, which includes a cannula 1 and a plurality of guide wires disposed inside the cannula 1. The casing 1 is made of PTFE, TTFE, PFA, PI, Nylon, etc., but not limited thereto, and has abiocompatible coating 6 coated on an outer surface thereof to reduce rejection reaction generated after the neurostimulation electrode enters a human body. The material of the guide wire is MP35N, 35NLT, stainless steel, platinum iridium alloy, nickel titanium alloy, etc., which are not limited herein. In this embodiment, the guide wire may be single-stranded or multi-stranded, and the multi-stranded guide wire may be 1 × 3 strands, 1 × 7 strands, 1 × 19 strands, etc., which is not limited in this embodiment. Two of which, afirst guidewire 21 and asecond guidewire 22, are shown in fig. 1 and 2. The through holes for the guide wires to pass through are formed in the sleeve 1, the number of the through holes corresponds to that of the guide wires, and the guide wires pass through the through holes and are fixed in the sleeve 1, so that physical isolation is realized, conduction short circuit between the guide wires is avoided, and stimulation signals are better transmitted to nerves.

The nerve stimulation electrode also includes flexible contacts, the number of which in this embodiment corresponds to the number of guide wires. In fig. 1 and 2, a firstflexible contact 31 is shown connected to thefirst wire 21, and a secondflexible contact 32 is shown connected to thesecond wire 22. The firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures may be springs, and the flexibility of the springs is used to realize the flexibility requirement of the flexible contacts. Other metals having good flexibility and ductility may be used, and a spring is preferably used in the present embodiment. The flexible characteristics of the flexible contact make the flexible contact have better extensibility after entering a human body, the deformation is softer, and the foreign body sensation of a patient is reduced. Because the nerve stimulation electrode that this embodiment provided is applied to medical field, consequently, flexible contact and seal wire are very soft and fragile certainly, simultaneously, also very high to precision, health requirement, consequently adopt laser welding's mode to connect, can avoid the rejection rate in the production process, can also satisfy precision, sanitary requirement simultaneously. The firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figure are respectively connected to one ends of thefirst guide wire 21, thesecond guide wire 22 and other guide wires not shown in the figure through laser welding, and the sleeve 1 is sealed by a plurality of flexible contacts andlaser welding points 4 of the guide wires, so that the use stability of the nerve stimulation electrode is ensured. Meanwhile, the firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures are insulated by thesealant 5, so as to avoid conduction short circuit between the flexible contacts, and enable the stimulation signal to be better transmitted to the nerve to be stimulated. The ends of the firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures, which are contacted with the nerve, are divided into a plurality of sub-contacts, the number of the sub-contacts is determined according to medical requirements, and the sub-contacts are simultaneously contacted with the nerve.

As shown in fig. 1 and 2, the end of the nerve stimulation electrode not provided with the flexible contact is also sealed with glue between thefirst guide wire 21, thesecond guide wire 22 and other guide wires not shown in the figure, further insulated by theglue 5, and the end part is sealed with the sleeve 1 by thelaser welding point 4 of laser welding. When the nerve stimulation electrode is used, the end is not implanted in the patient.

As shown in fig. 3, in this embodiment, in order to make the guide wire have a longer service life and bear more bending times, the guide wire is set to be spiral in this embodiment, the tensile strength and flexibility of the guide wire are improved by the spiral, so as to achieve the purpose of bearing more bending times and prolonging the service life, and meanwhile, the resistance value of the guide wire can be reduced by the spiral. In order to make the nerve stimulation electrode have better signal conductivity as a whole, the sleeve 1 is filled with ametal material 7 having better conductivity, such as gold, silver, and other metal materials, which are not limited herein. The filledmetal material 7 accounts for 10-50% of the volume of a single guide wire. The resistance can be reduced by 5 to 20 times after themetal material 7 is filled.

When the nerve stimulation electrode provided by the embodiment is used, one end of the connecting flexible contact is placed in the inner cavity of the puncture needle, a doctor punctures the puncture needle into the body of a patient, and the nerve stimulation electrode enters the body of the patient together with the puncture needle. When the puncture needle reaches the designated position, the puncture needle is withdrawn, and the flexible contact and part of the guide wire and the sleeve are left in the body of the patient. The other end of the nerve stimulation electrode is arranged outside the body of the patient and is connected with a signal generator of the nerve stimulation electrode.

As the puncture needle is withdrawn, the firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures are deformed correspondingly along with the muscle, the bone and the like of the patient in the patient body to form an inverted structure and contact the designated nerve. After the deformation, the firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures are retained and fixed in the patient's body because the skin and flesh of the patient are not cut. After the puncture needle is withdrawn, the directions of the firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures, which are opened and deformed, may be the same, as shown in fig. 1, so that the formed inverted structure hooks the human tissue in the same direction to prevent the nerve stimulation electrode from being displaced in a single direction, and specifically, when it is required to prevent the nerve stimulation electrode from being displaced outwards, the arc-shaped protrusion of the inverted structure should be directed toward the direction in which the nerve stimulation electrode enters; on the contrary, when the nerve stimulation electrode needs to be prevented from being displaced inwards, the arc-shaped bulge of the inverted structure faces the direction in which the nerve stimulation electrode is pulled out. After the puncture needle is withdrawn, the directions of the firstflexible contact 31, the secondflexible contact 32 and other flexible contacts not shown in the figures, which are opened and deformed, can also be different, as shown in fig. 2, the arc-shaped bulge of the inverted structure of the firstflexible contact 31 faces the direction of the entry of the nerve stimulation electrode; the arc-shaped bulge of the inverted structure of the secondflexible contact 32 faces the direction of pulling out the nerve stimulation electrode; in other flexible contacts not shown in the figures, a part of the arc-shaped bulges face the entering direction of the nerve stimulation electrode, and the other part of the arc-shaped bulges face the pulling direction of the nerve stimulation electrode. By the arrangement, the nerve stimulation electrode can be prevented from being displaced outwards, and the nerve stimulation electrode can be prevented from being displaced inwards.

Compare in prior art cutting skin meat and adopt the fixed back sutural form of anchor, the neural stimulation electrode that this embodiment provided does not need steps such as cutting, the fixed electrode of anchor, sewing of surgery operation, directly adopts the pjncture needle to implant neural stimulation electrode internal, and the time spent is still less, and the operation is simpler, has not only improved the efficiency of treatment, has reduced doctor's the work degree of difficulty simultaneously, has alleviateed doctor's work load. Due to the flexible property of the flexible contact, the flexible contact can deform and be fixed along with the body property of a patient without a fixed anchor in the body of the patient, and the use cost of a hospital is saved.

Because nerve stimulation electrode has a plurality of seal wires, every seal wire all connects stimulation signal generator, the flexible contact that every seal wire is connected all contacts the different regions of appointed nerve, simultaneously, between the seal wire, all do insulating processing between the flexible contact, consequently, when needs are amazing to the different positions of nerve, only need by the seal wire that the flexible contact that the relevant position contacted is connected with stimulation signal transmission to need carry out amazing nerve position can, can make stimulation position more pluralism, promote treatment.

Meanwhile, one end of each flexible contact, which is in contact with the nerve, is divided into a plurality of sub-contacts, and the sub-contacts simultaneously contact the nerve part to be stimulated and output a stimulation signal to the part, so that the directionality carried by the single-end flexible contact when outputting the stimulation signal is avoided. The stimulation signals output by the sub-contacts in different directions stimulate the nerves at the same time, so the directionality carried by the stimulation signals output by the single-ended flexible contact is offset, and the treatment effect is further improved.

Example two:

the present embodiment provides a neurostimulation device, which includes a neurostimulation signal generator and the neurostimulation electrode of the first embodiment. The nerve stimulation electrode is connected with a nerve stimulation signal generator, and a nerve stimulation signal generated by the nerve stimulation signal generator is input into the body of the patient through the nerve stimulation electrode in the first embodiment to stimulate the designated nerve.

While the present invention has been described with reference to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. Any modification which does not depart from the functional and structural principles of the present invention is intended to be included within the scope of the claims.

Claims (12)

1. A nerve stimulation electrode comprises a sleeve and a plurality of guide wires arranged in the sleeve, and is characterized by further comprising a flexible contact, wherein the flexible contact is connected to one end of each guide wire;

the nerve stimulation electrode stretches into the body, the flexible contact is deformed in the body and contacts with the nerve, and the deformed flexible contact is fixed in the body.

2. The neurostimulation electrode of claim 1, wherein: the flexible contact is connected with the guide wire through laser welding, and the sleeve is blocked by a welding point of the flexible contact and the guide wire.

3. The neurostimulation electrode of claim 1, wherein: the flexible contacts are insulated by sealing compound.

4. The neurostimulation electrode of claim 1, wherein: one end of the flexible contact, which is contacted with the nerve, is divided into a plurality of sub-contacts, and the sub-contacts are simultaneously contacted with the nerve.

5. The neurostimulation electrode according to any one of claims 1 to 4, wherein: the flexible contact is a spring contact, or the flexible contact is a flexible metal contact.

6. The neurostimulation electrode according to any one of claims 1 to 4, wherein: the guide wire is made of MP35N, 35NLT, stainless steel, platinum-iridium alloy and nickel-titanium alloy.

7. The neurostimulation electrode of any of claims 1 to 4, wherein: the guide wire is helical.

8. The neurostimulation electrode according to any one of claims 1 to 4, wherein: the sleeve is made of PTFE, TTFE, PFA, PI and Nylon.

9. The neurostimulation electrode according to any one of claims 1 to 4, wherein: through holes for the guide wires to pass through are formed in the sleeve, the number of the through holes corresponds to that of the guide wires, and the guide wires pass through the through holes and are fixed in the sleeve.

10. The neurostimulation electrode of claim 9, wherein: and the sleeve is filled with a metal conductor.

11. The neurostimulation electrode according to any one of claims 1 to 4, wherein: the outer surface of the cannula is coated with a biocompatible coating.

12. A neurostimulation device, which comprises a neurostimulation signal generator and the neurostimulation electrode of any one of claims 1 to 11, wherein the neurostimulation electrode is connected with the neurostimulation signal generator, and the neurostimulation signal generated by the neurostimulation signal generator is input into the body by the neurostimulation electrode to stimulate the nerve.

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